Telmisartan And Hydrochlorothiazide

Treats hypertension, alone or with other antihypertensive agents. ANDA 91351, held by Lupin. Hydrochlorothiazide; Telmisartan.

As of Nov 15, 2026, ANDA 91351 (Telmisartan And Hydrochlorothiazide), held by Lupin, was first approved by FDA on Aug 7, 2014, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 7, 2014
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Telmisartan and hydrochlorothiazide tablets are combination of an angiotensin II receptor blocker (ARB) and a thiazide diuretic indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions Telmisartan and hydrochlorothiazide tablets are not indicated for initial therapy Telmisartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 7, 2014	Original application	Approved	None posted

Products

3 strengths and forms


Telmisartan And Hydrochlorothiazide12.5MG;40MG · tablet;oral	Hydrochlorothiazide; Telmisartan	Discontinued
Telmisartan And Hydrochlorothiazide12.5MG;80MG · tablet;oral	Hydrochlorothiazide; Telmisartan	Discontinued
Telmisartan And Hydrochlorothiazide25MG;80MG · tablet;oral	Hydrochlorothiazide; Telmisartan	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Apr 26, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Apr 26, 2023	Supplement 10Labeling · Standard review	Approved	None posted
May 7, 2019	Supplement 2Labeling · Standard review	Approved	None posted
May 7, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Nov 13, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Aug 7, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 91351
Drugs@FDA: Overview at FDA
Company: Lupin

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters